Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

NCT01238341 | Completed Results

• 1 other identifier: Pancreatobiliary disorders
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).

Conditions

Pancreatobiliary Disease; Altered Gastric Anatomy

Keywords

Pancreatobiliary disease in patients with altered gastric anatomy.

Outcome Measures

Primary Outcomes (1)

• Papilla or Duct-enterostomy Was Reached

  During procedure, up to 3 hours

Secondary Outcomes (3)

• Successful Cannulation of the Duct of Intent

  During procedure, up to 3 hours

• Successful Endoscopic Therapy

  During procedure, up to 3 hours

• Total Procedure Time

  During procedure, up to 3 hours

Study Arms (1)

Pancreatobiliary disease

Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease.

Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

Endoscopic Retrograde Cholangiopancreatography (ERCP) PROCEDURE

An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy

Pancreatobiliary disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.

You may qualify if:

• Subject is 18 years or older
• Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
• Subject has altered gastric anatomy
• Subject must be able to give informed consent.

You may not qualify if:

• Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
• The subject is unable to give informed consent

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands at UF Endoscoppy Center

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Wagh MS, Draganov PV. Prospective evaluation of spiral overtube-assisted ERCP in patients with surgically altered anatomy. Gastrointest Endosc. 2012 Aug;76(2):439-43. doi: 10.1016/j.gie.2012.04.444. No abstract available.

  PMID: 22817798 DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Peter V. Draganov
• Organization: University of Florida

Peter.Draganov@medicine.ufl.edu

(352) 273-9472

Study Officials

• Peter Draganov, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: June 1, 2007
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 23, 2015
• Results First Posted: October 5, 2015

Record last verified: 2015-10

Locations

US (1)